drugset / Trial / NCT01638000
A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.
Timeline
- Start
- 2012-06-12
- Primary completion
- 2013-04-24
- Completion
- 2013-04-24
Outcome
Missed primary endpoint
registry analysis (unspecified test); Mirabegron 50 mg vs Solifenacin 5 mg; p = 0.15; least squares mean difference -0.18 (95% CI -0.42 to 0.06); ANCOVA; NCT01638000 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirabegron | Other / unclassified | 50 mg | Oral |
| Comparator | Solifenacin | Small molecule | 5 mg | Oral |